Dalfampridine extended-release is known as Ampyra when prescribed for patients with multiple sclerosis (MS) to improve their walking ability. The treatment, developed by Acorda Therapeutics, was seen to have similar effects in patients with walking difficulties after a stroke.

The Phase 1 trial (NCT01468350) consisted of two parts. Both used a so-called cross-over design, in which patients first receive the active treatment and then switch to placebo, or vice versa.

In the first phase, 11 CP patients were randomized to receive a single dose of dalfampridine or placebo and wait for two days before switching groups for another single dose.

The second part, in which 24 patients participated, was made up of twice-daily dosing for a week, and a washout period of one week before switching groups.

There were no serious adverse events during the study, and no one stopped the treatment because of side effects. Analyses showed that headache, fatigue, and insomnia were more common after dalfampridine treatment. In addition, patients experienced diarrhea and nausea to an equal extent after both dalfampridine and placebo.

Researchers did not note any new side effects, besides those reported in earlier studies.

Although the trial was small, researchers examined if the treatment produced any notable benefits. Among the 24 patients in the second part, the majority mostly had problems with hand movements, while only 38 percent having walking difficulties as the dominant feature.

Initial analyses suggested that patients may have improved their walking speed after dalfampridine treatment, but a comprehensive analysis failed to show any differences between the dalfampridine and placebo groups.

Based on these observations, the research team concluded that it is not worth to pursuing further trials of dalfampridine in CP patients.

Magdalena is a writer with a passion for bridging the gap between the people performing research, and those who want or need to understand it. She writes about medical science and drug discovery. She holds an MS in Pharmaceutical Bioscience and a PhD — spanning the fields of psychiatry, immunology, and neuropharmacology — from Karolinska Institutet in Sweden.

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